!e Hon Nicola Roxon MPMinister for Health and AgeingParliament HouseCanberra ACT 2600

7 April 2010

Concerning the -Proposed Healthcare Identi!ers Regulations 2010

Dear Minister

!ank you for giving us an opportunity to submit feedback on Draft Regulations, which are proposed to be issued as subordinate legislation to the Healthcare Identi"ers Bill 2010.

We appreciate that the regulations, i.e., the ‘statutory rules’ that are supplementary to a Bill, are the most common form of ‘subordinate legislation’, and provide essential detail within the statutory structure or framework of the Bill, as conceived by its framers. Even after the Bill is passed, and takes the shape of an Act, the regulations being an extension of the principal Act can be periodically reviewed, modi"ed and revised in accordance with the constant changes that are taking place in the socio-legal environment, without having to seek any amendment of the principal Act. !us, the regulations provide the statute with an inherent #exibility and adaptability that, in turn, render a dynamic dimension thereto.

We affirm our whole-hearted support to the enactment of Proposed Healthcare Identi"ers Regulations 2010, and recall the following quotation from 1893, which is still relevant today:

“Statutory rules are themselves of great public advantage because the details ... can thus be regulated after a Bill passes into an Act with greater care and minuteness and with better adaptation to local or other special circumstances than they can possibly be in the passage of a Bill through Parliament. Besides, they mitigate the inelasticity which would otherwise make an Act unworkable and are susceptible of modi"cations ... as circumstances arise.”

However, it has to be ensured that the regulations must:• comply with any preconditions set out in the principal Act, such as consultation with

speci"ed office-holders or bodies,• be consistent with the purpose and intent of the principal Act,• not confer discretionary power, unless the principal Act allows this sort of delegation.

Regulations should also be capable of being challenged in courts on various grounds, including:• repugnance to the common law• being unreasonably oppressive or unjust• being uncertain• being for an improper purpose

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Speci!c Suggestions on Proposed Healthcare Identi!ers Regulations 2010 (“Regulations”)1. Regulation 3, inter alia, de"nes the term sole practitioner as “a person who is both an individual

healthcare provider and a healthcare provider organisation.” !is de"nition appears to be anomalous because; "rstly, an ‘individual’ cannot be an ‘organisation’ at the same time; secondly, the word ‘sole’ connotes ‘individual’ or ‘solo’, therefore, it is quite misleading to dub an ‘organisation’ a ‘sole practitioner’. When everywhere else in the Regulations, an individual healthcare provider and a healthcare provider organisation have been distinguished, and they have been covered under separate subregulations; e.g., see subregulation (1) and (2) of Regulation 7, it de"es logic as why the two entities – individual and organization – have been clubbed together in this de"nition alone.

2. Regulation 4 attempts to elucidate as to what comprises a national registration authority for the purpose of Section 8 of the proposed Healthcare Identi"ers Act 2010 (“Act”), but it apparently fails to give an easy-to-understand description of national registration authority as the one given therein is long-winded and puzzling.

3. Regulation 5, which speci"es the classes of individual healthcare providers, refers to ‘a registration authority’, and not to ‘a national registration authority’, thereby; giving rise to confusion as to whether there is/are any other registration authority/ies besides national registration authority. Curiously, Regulation 7(1), again, refers to ‘a national registration authority’. It is suggested that ‘same nomenclature’ should be used throughout the Act and Regulations to avoid any misinterpretation/confusion as to their intended meaning.

4. Regulation 7(4) stipulates, “If the information given does not satisfy the body that asked for the information, that body does not have to assign a healthcare identi!er to the healthcare provider.” It is suggested that in Regulation 7(4), besides the provision for ‘not … assign(ing) a healthcare identi!er’, there should be an additional provision for either imposition of penalty or disbarment of such healthcare provider from the professional association/body with which he/she is registered, in case he/she fails to set right the dissatisfactory portion in the information given by him/her within a prescribed period, say, 15 days or one month.

5. Regulation 8(1) prescribes the additional information, pertaining to individual healthcare providers, which is supplemental to the identifying information prescribed in Section 7(a) to 7(f ) of the Act. It is proposed to include each of the following in the scope of identifying information under Regulation 8(1) –

(a) Particulars and Proof of Academic/Professional Quali"cation of Healthcare Provider(b) Details of Healthcare Provider’s previous disbarment by the registering authority, if any(c) ‘Area of medical sciences’ in which Healthcare Provider has obtained ‘specialisation’, if any,

and the ‘length’ of his/her experience in providing healthcare

6. Regulation 8(2) prescribes the additional information, pertaining to healthcare provider organisations healthcare providers, which is supplemental to the identifying information prescribed in Section 7(a) to 7(d) of the Act. It is proposed to include each of the following in the scope of identifying information under Regulation 8(2) –

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(a) name, address, phone number, email and IHI of each employee who: (i) is an identi"ed healthcare provider; and (ii) provides healthcare as part of his or her duties; and

(b) name, address, phone number and email of responsible officer and(c) name, address, phone number and email of organisation maintenance officer

7. Two new terms, i.e., ‘office holder’ and ‘unincorporated association’, have been introduced in Regulation 9(1)(iv), without specifying their meaning and implication in either the Regulations or the Act. It is a slightly confusing as to how an unincorporated association has been considered an organization in Regulation 9(1)(iv). It is also not clear as to whether the term ‘body’ used in Regulation 9(1)(iv) purports to include corporate bodies as well because in both the Act and the Regulations, the corporate bodies engaged in providing healthcare have been omitted from the de"nition of ‘healthcare provider organizations’. It is suggested that Regulations shall be suitably modi"ed so as to remove the ambiguity qua the omission of corporate bodies and inclusion of unincorporated association in the de"nition of ‘healthcare provider organization’.

8. Regulation 10, subregulation (8)(a) stipulates that “a healthcare provider organization that asks the service operator to disclose a healthcare identi!er must … maintain a retrievable record of each person the provider has authorised to access healthcare identi!ers from the service operator, including each person’s name, designation and …”. It is suggested that the ‘retrievable record’ shall also include the ‘permanent addresses’ of all concerned persons, who have been authorised to access healthcare identi"ers.

9. It is suggested that the term information, as used in Regulation 11, subregulation (2), should mean to, inter alia, include ‘address’, ‘phone number’ and ‘email address’ of the person, who was authorised by the healthcare provider to access healthcare identi"ers.

10. As explained below, there is some patent confusion regarding the provisions for imposition of penalty in the Regulations:

(i) Quite a few regulations prescribe imposition of 50 penalty units for non-compliance or non-ful"llment of the conditions set forth therein, but the rami"cations of 50 penalty units as well as accumulation of more than 50 penalty units by a healthcare provider have nowhere been clari"ed in the Regulations. In order that the incurrence of penalty units is taken seriously, the repercussions thereof in terms of ‘monetary "ne’ and/or ‘imprisonment’ could also be speci"ed in the Regulations.

(ii) Nonetheless, the provision for imposing penalty, without any apparent justi"cation, has been omitted in some of the regulations, and/or subregulations that touch the highly critical aspects. For instance, there is no provision of penalty for the errant healthcare provider who fails to ful"ll the obligations cast upon him/her by Regulation 10, subregulation (8)(b) that requires a healthcare provider “to ensure that information it exchanges with, or receives from, the service operator is kept secure so that it is not accessed, modi!ed or disclosed to or by unauthorized persons…”.

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(iii) Finally, there is no provision in the Regulations for imposing ‘higher number of penalty units’ in case a defaulter violates a regulation or subregulation repeatedly. It is suggested that in the event of repeated violations, the number of penalty units should be successively increased for each ‘subsequent’ violation after the ‘"rst’ violation.

11. Since there are a number of terms and expressions that have been used in both Regulations and Act but their meaning has not been speci"ed in Regulations, therefore, to eliminate any ambiguity or misinterpretation as to the implications and connotation of such terms and expressions, it is suggested to incorporate the following clari"cation:

“Terms and expressions, used in the Regulations, whose meaning has not been speci"ed herein, shall be construed to carry the same meaning as ascribed to them in the Act.”

ConclusionHello Medical, working in the domain of eHealth Communication and Healthcare Collaboration, is a strong supporter of all such Health Reforms aimed at reducing the costs and improving the quality of healthcare. We, at Hello Medical, have envisioned a robust, dynamic and responsive Healthcare Information System for Australia that facilitates unimpeded and timely sharing of information among healthcare providers, research agencies and responsible authorities; with the underlying objective of making available speedier and more economical healthcare to one and all. In keeping with the continued growth of our country, the Healthcare Information System is bound to operate on much larger scales; therefore, it is imperative that effective checks and controls must be in place to ensure that the system doesn’t fail, or, at least, the incidence of its failure is minimal and controllable; and toward this, we strongly support the enactment of Health Identi"ers Regulations 2010, which, in our opinion, aptly embody the necessary checks and controls that are required to ensure smooth functioning of the Healthcare Information System in our country.

We trust you will duly consider our feedback, and thank you for your attention. We would welcome the opportunity to elaborate on this submission, or provide further information.

Yours sincerely

Brent HallChief Operating Officer

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